- A leading biotech is seeking a motivated individual with substantial downstream process development and manufacturing experience with biologics to be part of a growing company developing novel vaccines,
- They will work within a highly collaborative team environment to assist in developing and implementing operational plans to meet project timelines and the company's business objectives.
- The successful candidate will have responsibility for the technical oversight and management of outsourced downstream process activities including development, validation, and GMP manufacturing of monoclonal antibodies at top tier external contract development and manufacturing organizations (CDMO).
- They will collaborate with various internal functions including upstream manufacturing, quality control, quality assurance, regulatory, and supply chain to ensure best practices are implemented and followed at external contract manufacturing and testing labs, and internally.
Specific responsibilities include:
- Manage all downstream process development, optimization, validation, and GMP manufacturing activities at a top tier CDMO for clinical supply through launch/BLA -purification, formulation, and fill/finish
- Co-author batch records, validation protocols/reports in collaboration with the CDMO
- Use creative problem-solving skills to independently troubleshoot experimental challenges -interpret data, define problems, establish facts, draw valid conclusions and make decisions
- Assist with the trending of process development, validation, and manufacturing data for continuous process improvement
- Manage drug supply/demand forecasting estimates
- Manage operational budget and timelines
- Participate in batch release with QA and QC including the review of batch records and supportive data.
- Provide technical input for the resolution of investigations, deviations, out-of-specification/out-of-trend, change control, and CAPAs at contract sites
- Author relevant sections of IND/IMPD regulatory filings
Education / Experience / Skills:
- S., M.S. or Ph.D. in chemical engineering, bioengineering, biochemistry, or equivalent.
- 10+ years (depending on education) of progressive hands-on experience in process development and GMP manufacturing of monoclonal antibodies in the pharmaceutical/biotech industry
- Substantial experience with managing external CDMOs
- Process validation experience in support of late stage clinical programs preferred (DoE,IQ/OQ/PQ)
- Fill/Finish experience preferred but not essential
- Advanced understanding of the application of FDA regulations and ICH guidelines from early development through commercial products